QA Validation Manager - Frederick, MD | Biospace
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QA Validation Manager

Leidos Biomedical Research, Inc.

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Location:
Frederick, MD
Posted Date:
9/19/2017
Position Type:
Full time
Job Code:
640337
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Quality Assurance, Validation,

Job Description

PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES
The Validation Manager is responsible for:
Managing the Equipment Validation and Calibration groups consisting of at least four (4) staff
Project management of calibration activities and equipment validation and/or requalification in accordance with SOPs, master plans, regulatory expectations and industry standards
Management and oversight of the calibration group and equipment validation/calibration contractors
Scheduling, planning, managing and following up on validation/calibration activities, projects and deliverables, timelines, new equipment specifications, installation and use, facility/system/process improvement, equipment and systems modifications and additions and requalification
Timely development and completion of validation protocols and validation summary packages
Reviewing and approval of calibration and/or validation work requests in the equipment management database and change control system
Providing project status reports to QA and VCMP management
Participate in meetings with the client
Providing relevant reports and metrics both internally and to the client

Requirements

BASIC QUALIFICATIONS:
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education).
Foreign degrees must be evaluated for U.S. equivalency
(6) years of experience in progressively responsible job related experience including 2 years in a supervisory role
Must have experience in a cGMP environment (biologics preferred)
Experience managing equipment validation projects
Experience managing calibration activities
Experience supervising contractors
Ability to establish a validation strategy to manage multiple projects effectively and efficiently
Knowledge of current regulatory expectations and industry standards relating to compliance
Possess a working knowledge of quality systems
Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS:
Candidates with these desired skills will be given preferential consideration:
Project Management Professional (PMP) Certification
Continuous knowledge development of industry regulations and best practices
Possess expert knowledge in equipment validation and calibration and broad knowledge related to quality assurance